THE ARTHROFILE
FDA 510(k) clearance K812506 · decided 1981-09-24
Clearance details
- K-number
- K812506
- Device name
- THE ARTHROFILE
- Applicant
- Dyonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-01
- Decision date
- 1981-09-24
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- HTR
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dyonics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIODYNAMICS FEMORAL CANAL BRUSH #1201 (K870349) | Biodynamic Technologies, Inc. | 1987-02-13 |
| BIODYNAMICS SMALL JOINT BRUSH #1203 (K870333) | Biodynamic Technologies, Inc. | 1987-02-13 |
| ACETABULAR BRUSH #1202 & FEMORAL CON. BRUSH #1202 (K870329) | Biodynamic Technologies, Inc. | 1987-02-13 |
| RICHARDS ACETABULAR BRUSH (K813093) | Richard'S Medical Equip., Inc. | 1981-11-20 |
| MICRO RASPS (K780771) | Amsco Co. | 1978-05-16 |
| INTERMEDULLARY BRUSH (K771016) | Howmedica Corp. | 1978-01-12 |
| RASPS FOR SCRAPING BONE (K771745) | Depuy, Inc. | 1977-09-28 |
| PROSTHESIS, TOTAL HIP-RASP (K760109) | Orthopedic Equipment Co., Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.